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Mask Effectiveness Test Checklist of EN 14683, EN 149, and ASTM F2100

Mask INFO
1. Mask Factory: Complete Guide to Building a Mask Production Line
2. Mask Type: How can We Identify Shape, Use, and Standard of Face Mask?
3. How to Select the Best Mask Manufacturing Machine for the Mask Factory?
4. Mask Effectiveness Test Checklist of EN 14683, EN 149, and ASTM F2100
5. An overview of masks
6. The Common FAQ about the Use of N95 Masks

The standards for face masks are ASTM F2100, EN 14683, NIOSH, and EN 149, each with its own classification methods and testing items for different mask applications. This post is a mask test checklist for these four mask standards, and it is the most concise index of mask test.

Before introducing the mask test list, we should understand some basic concepts of the mask test, which can help us better understand the mask test.

  • Medical face mask
    Medical device covering the mouth and nose providing a barrier to minimise the direct transmission of infective agents between staff and patient.
  • BFE (bacterial filtration efficiency)
    BFE: efficiency of the medical face mask material as a barrier to bacterial penetration
  • Differential Pressures
    Air permeability of the mask, measured by determining the difference of pressure across the mask under specific conditions of air flow, temperature and humidity.
  • Colony Forming Unit (cfu)
    Unit by which the culturable number of micro-organisms is expressed.
  • Cleanliness
    Freedom from unwanted foreign matter
  • Cleanliness – microbial
    Freedom from population of viable micro-organisms on a product and/or a package
  • Cleanliness – particulate matter
    Freedom from particles that are contaminating a material and can be released but are not generated by mechanical impact
  • Infective agent
    Micro-organism that has been shown to cause surgical would infections or that might cause infection in the patient, members of staff or other
  • Aerosol
    Gaseous suspension of solid and/or liquid particles, the particles having a negligble falling velocity.
  • Filter
    Material used for mechanical and physical separation or deposition of aerosol particles (liquid or solid) from the inhaled and exhaled air.
  • Splash resistance
    Ability of a medical face mask to withstand penetration of synthetic blood projected at a given pressure.
  • Flammability
    Those characteristics of a material that pertain to its relative ease of ignition and relative ability to sustain combustion.

EN 14683 mask test list

EN 14683: 2014 Medical face masks – Requirements and test methods. This standard specifies construction, design, performance requirements and test methods for medical face masks intend to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. The mask test list is as follows.

  • General, all tests shall be carried out on finished products or samples cut from finished products, if applicable in their sterile state.
  • Bacterial filtration efficiency testing of masks according to EN 14683 Annex B.
  • Differential pressure testing of masks according to EN 14683 Annex C.
  • Splash resistance pressure test for medical masks according to ISO 22609.
  • The bioburden of medical masks should be ≤ 30 cfu/g according to EN ISO 11737-1 test.
  • Biocompatibility testing of masks according to EN ISO 10993-1.

Summary of performance requirements for medical face masks

Test Type Ⅰ Type Ⅱ Type ⅡR
Bacterial Filtration Efficiency BFE (%) ≥95 ≥98 ≥98
Differential Pressure (Pa/cm2) <29.4 <29.4 <49.0
Splash Resistance Pressure (kPa) Not required Not required ≥16.0
Microbial Cleanliness ≤30 ≤30 ≤30
Type I medical face mask should only be used for patients and other persons to reduce the risk of spread of infections, particularly in epidemic or pandemic situations. Type I masks are not intended for use by healthcare professionals in an operating room or in other medical settings with similar requirements.

EN 149 mask test list

EN 149: 2001+A1:2009, respiratory protective devices – filtering half masks to protect against particles – Requirements, testing, marking. This standard specifies minimum requirements for filtering half masks as respiraotory protective devices to protect against particles except for escape purpose. The mask test list is as follows.

  • Visual inspection
  • Walking test
  • Work simulation test
  • Leakage test
  • Flammability
  • Carbon dioxide content of the inhalation air
  • Strength of attachment of exhalation valve housing
  • Breathing Resistance
  • Clogging
  • Penetration of filter material
  • Marking

EN 149 standard specifies minimum requirements for filtering half masks as respiratory protective devices to protect against particles except for escape purposes. Laboratory and practical performance tests are included for the assessment of compliance with the requirements.

Penetration of filter material

grade Maximum penetration of test aerosol
Sodium chloride test 95 L/min, % Paraffin oil test 95 L/min, %
FFP1

FFP2

FFP3

20

6

1

20

6

1

Breathing resistance requirement

grade Maximum permitted resistance (mbar)
inhalation exhalation
30 L/min 95 L/min 160 L/min
FFP1

FFP2

FFP3

0.6

0.7

1.0

2.1

2.4

3.0

3.0

3.0

3.0

ASTM F2100 mask test list

ASTM F2100: standard specification for performance of materials used in medical face masks. This standard covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare services such as surgery and patient care. The mask test list is as follows.

  • Bacterial Filtration Efficiency / BFE
    Determine the bacterial filtration efficiency as directed in test method ASTM F2101.
  • Differential Pressure
    Determine breathing resistance or differential pressure as directed in EN 14683, Annex C.
  • Sub-Micron Particulate Filtration
    Determine particulate filtration efficiency as directed is test method ASTM F2299.
  • Resistance to Penetration by Synthetic Blood
    Determine synthetic blood penetration resistance as specified in test method ASTM F1862.
  • Flammability, determine flammability as specified in 16 CFR Part 1610.

Medical face mask material requirements by performance level

Mask Test Level 1 barrier Level 2 barrier Level 3 barrier
Bacterial filtration efficiency, % ≥95 ≥98 ≥98
Differential pressure, mm H2O/cm2 <5.0 <6.0 <6.0
Sub-micron particulate filtration efficiency at 0.1 micron, % ≥95 ≥98 ≥98
Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result 80 120 160
Flame spread Class 1 Class 2 Class 3

NIOSH N95 mask test list

N95 type mask, also called N95 respirator, is one of the 9 types of NIOSH (National Institute for Occupational Safety and Health) certified anti-particle masks. The term “N” means not suitable for oily particles, such as droplets produced by people talking or coughing are not oily.

The term “N95” is simply a definition developed by this organization to describe the efficiency rating of particulate blockage. N95 Respirators block 95% of particles that are greater than 0.3 microns in size. This particulate filtration efficiency metric can be compared to other testing methods including the ASTM F2100-07, which actually measures the filtration of smaller particles.

To designate an N95 respirator as medical or surgical, it must be approved by the FDA, which is an independent designation from the NIOSH approval.

NIOSH N95 mask certification

Submit a questionnaire and photos to NPPTL (the questionnaire is provided by NPPTL). After NPPTL’s assessment and approval, a company code and other relevant information will be given to the N95 mask manufacturer. After receiving the relevant documents from NPPTL, the mask manufacturer needs to provide the following information.

  • Pre-test data
  • Drawings
  • Assembly Matrix
  • Draft approval labels
  • QA manual
  • Process Quality Control Plan
  • Service Life Plan
  • User’s Instructions
  • Test samples and Hardware

Payment for testing is required with the submission of the information. If the information fails, NPPTL will require rectification and re-provision. After the mask manufacturer obtains N95 certification, NIOSH will conduct annual sampling of certified masks by the manufacturer to ensure that the N95 masks meet the requirements.

 

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